Effect of surgical treatment on the sleep quality in people with epilepsy

Withdrawn

Conditions: sleep disturbance
10040998

Registration Number: NL-OMON41884

Lead Sponsor: Stichting Epilepsie Instellingen Nederland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

An adult (18 years or older) with intractable epilepsy treated in SEIN Zwolle, who underwent resective surgery or had an Vagus Nerve Stimulator or Deep Brain Stimulator implanted.
Before surgery a night sleep PSG/EEG recording is performed. This recording was performed 12 months before surgery at most, recorded a minima of 6 hours of sleep and no nocturnal (secundairy) generalized seizure(s) occured during the night

Exclusion Criteria

Using a questionnaire, (which is included in the application, and will be given to prospective participants when asked to participate in this study), we exlude participants who have a(n):
- educational level below special elementary education
- history of alcohol or drug abuse during the 1-year period prior to trial participation (criteria for abuse are implemented from health care clinic Jellinek, specialized in abuse)
- the diagnosis of illnesses that affect sleep, like heart failure, cardiac arrythmias pulmonary disease, or sleeping disorders, existing before the diagnosis of epilepsy was made

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Differences in polysomnography (PSG) / EEG parameters before and after surgery<br /><br>(sleep latency, sleep efficiency, wake after sleep onset, sleep architecture<br /><br>(distribution of all sleep stages))</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Differences in scores sleep scales (Groninger Sleep Quality) before and after<br /><br>surgery<br /><br>Differences in scores on quality of life scales QOLie-31-P(v2), before and<br /><br>after surgery<br /><br>Differences in scores on neuropsychological measures of memory (WMS-R), before<br /><br>and after surgery</p><br>